WO2017017057A1

WO2017017057A1 - Prosthesis shaft retaining device and system composed of prosthesis shaft and prosthesis shaft retaining device

Info

Publication number: WO2017017057A1
Application number: PCT/EP2016/067659
Authority: WO
Inventors: Sonja WAGNER; Alice FREY; Walter LUNZER
Original assignee: Otto Bock Healthcare Products Gmbh
Priority date: 2015-07-29
Filing date: 2016-07-25
Publication date: 2017-02-02
Also published as: CA2992907C; DE102015112406B4; RU2687634C1; ES2734139T3; US11219538B2; CN108289745A; TR201909617T4; CN108289745B; US20180214284A1; EP3328323A1; DE102015112406A1; CA2992907A1; EP3328323B1

Abstract

The invention relates to a prosthesis shaft retaining device and a system for securing a prosthesis shaft (4) to an upper extremity, comprising a securing part (2) that can be guided along the torso (1) below the axilla of the contralateral, unprovided side of a patient, and a coupling element (9) which can be secured to the prosthesis shaft (4) and connected to the securing part (2), wherein the coupling element (9) is displaceably mounted on the securing part (2).

Description

Denture shaft prosthesis device and system of prosthesis shaft and prosthesis shaft retaining device

The invention relates to a prosthesis shaft holding device for securing a prosthesis shaft to an upper extremity, with a securing part, which can be guided along the torso below the axilla of the contralateral, unsupervised side of a patient, and with a coupling element, which can be fixed to the prosthesis shaft and connected to the securing part as well as a system of prosthetic socket and prosthesis shaft holding device. The prosthetic shaft holding device is particularly suitable and provided for securing upper arm stems to a humeral stump.

US 5,403,268 A relates to an orthosis that supports dislocated shoulders. A cuff is placed around the upper arm, a shoulder strap extends from the collarbone below the opposite armpit around the torso. The cuff is attached to the shoulder strap via straps and buckles. Such a device is not intended for prostheses.

In the event of a loss or absence of the forearm, a prosthetic restoration is required in which a grasping element or a prosthetic hand is attached to a forearm element. Within the lower arm element drive means, control devices and energy storage can be arranged. For attachment of the prosthetic hand and the forearm part, these components are usually hinged to a humeral shaft, which is fixed to the remaining upper arm stump of the patient. The determination of a Oberarmschaftes on the torso can be done on elaborate belt constructions in which the straps are guided along the torso. Belts or straps are passed along the contralateral side of the torso and secured to the prosthesis shaft so that the upper arm shaft is held firmly to the patient. Another way to define a prosthesis on an upper arm stump is in the so-called Saugschafttechnologie in which a liner made of a plastic or silicone material is pulled over the upper arm stump. The prosthesis stem of a dimensionally stable material serves as a receptacle for the liner with the stump. About mechanical locking means or negative pressure of the liner is held on the shaft. The problem here may be that the holding force that is applied between the liner and the stump, may not be sufficient to hold the prosthesis to the stump at a tensile load. Volumetric changes of the stump can lead to a reduction of the adhesive force. In addition, a feeling of insecurity in patients can occur when the arm prosthesis is held exclusively by the liner on the stump.

The object of the present invention is to provide a prosthesis shaft support device and a system of prosthesis shaft and prosthesis shaft retaining device with which, on the one hand, a secure fixing of the prosthesis shaft to the patient is ensured and, on the other hand, a free mobility of the shoulder joint is made possible.

According to the invention, this object is achieved by a prosthesis shaft holding device having the features of the main claim and a system comprising a prosthetic shaft holding device and a prosthesis shaft according to the independent claim. Advantageous embodiments and further developments of the invention are disclosed in the subclaims, the description and the figures.

The prosthetic shaft holding device for securing a prosthesis shaft to an upper extremity, with a securing part, which is guided along the torso below the axilla of the contralateral, unsupervised side of a patient, and with a coupling element which is fixable to the prosthesis shaft and connectable with the securing part sees in that the coupling element is displaceably mounted on the securing part. The prosthesis stem, especially in the form of a humeral shaft, is about a securing part fixed to the upper body of the patient. The securing part is guided underneath the patient's axilla on the unaided side, thereby ensuring that tensile forces exerted by the prosthesis shaft holding device on the securing part are absorbed via the torso and not over the neck area. The coupling element is fixed to the prosthesis shaft or fixed and slidably mounted on the securing part, whereby on the one hand the mechanical fixing of the prosthesis shaft is ensured on the securing part and on the other hand, the free mobility in the shoulder joint of the supplied side remains unaffected. The humerus moves with his condyle in the socket of the scapula, with only a quarter of the condyle is enclosed by the pan, allowing a great mobility of the shoulder joint. Furthermore, there is a joint capsule having a reinforcing band to hold the condyle in the socket. Other band guides does not show the shoulder joint, the cohesion of the joint is only effected by the muscles. The shoulder joint is thus the most flexible joint whose position on the trunk is also displaceable over the collarbone. Among other things, this high mobility leads to the fact that the conventional fastening of prosthetic shafts at the shoulder with straps and buckles leads to restrictions of movement, since these straps can not compensate the mobility. Due to the slidable mounting of the coupling element on the securing part, it is possible on the one hand to reduce the uncertainty of the patient by a mechanical definition, without, on the other hand, the mobility is restricted. The coupling element thus compensates the relative movement between the securing part and the prosthesis shaft, so that a physiological swinging of the supplied arm is made possible.

A further development of the invention provides that the coupling element can be detachably fastened to the prosthesis shaft. The solubility of the coupling element has the advantage that it can be manufactured and adapted independently of the prosthesis stem. The cleaning of the coupling element, if necessary with the necessary equipment for fixing to the can take place independently of the prosthesis stem, for example by washing.

The coupling element may be positively secured to the prosthesis shaft, so be arranged directly on the redeemed schaff, for example via Velcro, buckles or other fasteners. It is also possible to provide in a one-piece design of the coupling element a funnel-shaped receptacle in which the prosthesis socket is inserted or which is applied around the prosthesis stem around, so that slipping out of the prosthesis shaft is prevented in the distal direction. The coupling element can also be arranged on a sleeve or sleeve which is detachably fastened or attachable to the prosthesis socket. In this way, it is possible for the prosthesis user to easily put on the prosthetic retention device since the coupling element can be placed around the prosthesis shaft and fastened thereto by means of straps, buckles or hook-and-loop fasteners. It is also possible to design the sleeve or sleeve with a closed cross section, wherein the coupling element then forms out of the sleeve, is fastened or fastened.

The coupling element may be formed in several parts, for example, consist of a belt and the above-mentioned sleeve or sleeve, which then together form the coupling element. Alternatively, the coupling element is a traction device or belt, which is guided over the collarbone in the direction of the back in the region of the thoracic spine, deflected at a deflecting device and guided dorsal to the prosthesis shaft and fixed there. The coupling element may comprise a flexible tension member, such as a strap, strap or other tension member, either attached directly to the prosthesis shaft or fixed to the prosthesis shaft via the cuff or sleeve, which may be part of the coupling element. The tension element is preferably flexible and inelastic in order to ensure a secure association of the prosthesis shaft to the securing part. The tension element can be movable, in particular be guided slidably in a fixed or trained on the security part leadership. The guide may for example be formed by a recess in the securing part, alternatively, the guide may be set as a separate component on the securing part, for example in the form of a loop, a ring or a similar guide, and deflection of metal or plastic, preferably a closed Hollow cross section has to guide the tension element on the one hand and on the other hand to allow a relative displacement of the tension element to the guide. The coupling element is freely movable within the guide to allow the shoulder movement.

The coupling element can be displaceably guided in a protective sleeve or on a protective support in order to prevent or prevent friction between the torso or the shoulder and the coupling element. The protective sleeve or the protective pad rests on the torso on or on the torso in the applied state of the prosthetic shaft holding device, whereby the prosthetic shaft holding device can be worn both directly on the skin and above the clothing. Through the protective sleeve or protective pad, the friction between the coupling element and the underlying tissue, be it textile or skin, avoided.

The coupling element is preferably guided in the applied state on the front and the back of the supplied shoulder, wherein the region of the condyle can remain recessed. A front part of the coupling element extends over the collarbone in the direction of the shoulder blade, where it is coupled by the guide with the securing part and then guided again in the dorsal region of the axilla in the direction of the prosthesis shaft. By means of the coupling element, therefore, the front side of the prosthesis shaft holding device or of the prosthesis shaft is connected to the rear side of the prosthesis shaft holding device or the prosthesis shaft and coupled via the displaceable mounting and deflection on the securing part such that the respective forward and backward displacement of the arm and the prosthesis shaft is compensated relative to the torso by a displacement of the coupling element. The securing part can be designed as a flat blank and have an opening as an arm feedthrough. Alternatively, the securing part may be formed with end-side connecting elements, whereby the application and individualization of the securing part are facilitated. Through the opening as the arm feedthrough, it is possible that the securing part can be easily put on, since the arm of the contralateral side has to be simply passed through the arm passage to apply the securing part. If connecting elements are provided on the securing part, these are arranged on projections or regions of the securing part, which can be connected to each other, so that an opening is formed or the securing part can be applied around the shoulder, wherein a part of the securing part is guided along below the axilla ,

The securing part is designed so that it is guided predominantly dorsal in the applied state, so only a small part of the security part is guided frontally in the shoulder area, while the majority of the security part is positioned dorsal. In the frontal shoulder region, the securing part is preferably designed like a belt, so as not to impair the mobility of the shoulder joint or to minimize it as little as possible. In the area of the axilla, the securing part may have a padding, for example in the form of a filling with pearl-like plastics, which very well adapt to the anatomy of the user and follow the movements of the arm.

A development of the invention provides that the securing part in the applied state protrudes dorsally beyond the median plane in the direction of the prosthesis shaft. The guide for the coupling element is also positioned dorsally in the applied state of the prosthetic shaft holding device, so that no restrictions on the mobility in the chest area for the patient are present.

The securing part and / or the coupling element can be made of a textile material, spacer knitwear and / or foam material, which is a easy processing, easy donning and good washability.

The coupling element may be formed or guided as a loop, wherein either a direct connection with the Protesesenschaft or a determination about a mounting portion or a fastening device such as a sleeve, sleeve, clip or the like takes place.

The system according to the invention consists of a prosthesis shaft, in particular for receiving an upper arm stump, and a prosthesis shaft holding device, as described above.

Embodiments of the invention will be explained in more detail with reference to the accompanying figures. Show it:

Figure 1 - an applied prosthesis sheep holding device in rear view;

FIG. 2 shows an applied prosthetic shaft holding device in a frontal view;

FIG. 3 shows an applied prosthesis shaft holding device in a side view;

Figures 4a - 4d - prosthetic sheep holding devices in different

positions; such as

Figure 5 - - detailed representations of the prosthetic sheep holding device

FIG. 1 shows in a rear view a prosthetic shaft holding device which is attached to a patient. The prosthesis holding device has a securing part 2, which consists in the illustrated embodiment of a textile base body in which an opening 14 is formed as an arm feedthrough. As a result, the securing part 2 is guided in the applied state below the axilla of the unprovoked side. In the axilla area is a Upholstery 15 arranged, which may have as cushioning material foam or pearl-like plastics, such as polystyrene. The padding 15 ensures that the blood circulation in this area is not hindered, moreover, an adaptation to the anatomy of the user, whereby the movement of the unaided arm is not or only slightly limited. The securing part 2 may be formed as a one-piece body, which is cut from a sheet material. It is advantageous in terms of the fit, when the securing part 2 is made of a flat blank, wherein the blank has a back portion 3 and a belt-like or belt-like frontal section 11, wherein the frontal section 11 is shown in FIG. In the basic blank, the back portion 3 and the frontal portion 11 may have unconnected ends, which are advantageously joined together in the area of the axilla, for example, sewn to achieve a shape adapted to the anatomy of the shoulder. The back portion 3 is substantially larger than the frontal portion 11 and extends in the illustrated embodiment, medially from the trapezius muscle on the shoulder blade to beyond the median plane and extends laterally to the rear axilla area. By the corresponding stitching of the two free ends in the axilla area, the opening 14 results as an arm bushing, so that in the applied state, the securing part 2 is applied over a large area in the back area, the frontal section extends over the collarbone under the axilla and thus the security part 2 securely on the Torso 1 of the patient is defined.

The back section 3 extends beyond the median plane in the direction of the supplied upper limb, in which a prosthesis shaft 4 is fixed to an upper arm stump. The determination can be made for example via a prosthetic liner, which is pulled over the upper arm stump, not shown. The prosthetic liner can be held on the prosthesis shaft 4 mechanically or by negative pressure.

On the outside of the prosthesis shaft 4, a sleeve 5 or sleeve is arranged, the tight over a belt or other fastener is applied around the outside of the prosthesis shaft 4 around. Both the prosthesis shaft 4 and the sleeve 5 are flared in the proximal direction, wherein the distal end of the sleeve 5 has a smaller circumference than the proximal end of the prosthesis shaft 4, so that the prosthesis shaft 4 is not moved through the distal opening of the sleeve 5 can be. On the inside of the sleeve 5 may also be arranged a coating which is slip-resistant, so that the once applied sleeve 5 is firmly fixed to the prosthesis shaft 4. The sleeve 5 may also be formed with an open cross-section, that is rather in the form of a sleeve, wherein the open cross-section can be closed by means of closure devices, for example hook-and-loop fasteners, straps or other form-fitting elements.

As shown in FIG. 1, a dorsal extension 6 is fastened or formed on the sleeve 5 and extends in the medial direction onto the securing part 2. The dorsal appendage 6 extends substantially over the scapula towards the neck region of the patient. At the front of the sleeve 5, as shown in Figure 2, a frontal extension 7 is attached or formed, which extends in the front shoulder region in the direction of the collarbone of the supplied side. At the front extension 7 and the dorsal extension 6, a coupling element 9 is attached in the form of a flexible, preferably inelastic belt. The coupling element 9 extends over the collarbone on the supplied side in the direction of a guide 10, which is formed on the securing part 2 in the form of a bridge, a web, a ring or a loop. The coupling element 9 extends around the guide 10 around, so is only deflected and not impaired in the displaceability relative to the guide, and is fixed to the dorsal extension 6, for example, sewn or reversibly fixed via a Velcro. The coupling element 9 is slidably mounted on the guide 10, that is, that the coupling element is not fixed to the guide 10, but is movably mounted in it. Depending on the pulling direction, the coupling element 9 can be moved in one or the other direction. The guide 10 is arranged in the illustrated embodiment in the region of the spine, ie on the median plane when the prosthesis stem holding device is applied.

In a releasable attachment of the coupling element 9 on the dorsal extension 6 or the frontal extension 7, it is possible to adjust the effective length of the coupling element 9 and the prosthesis sheep holding device individually adapted to the respective patient.

FIG. 3 shows the applied prosthetic shaft holding device in a side view. It can be seen that the dorsal appendage 6 and the frontal appendage 7 include the dorsal and frontal shoulder joint, but release the shoulder joint itself and secure the prosthesis socket 4 via the sleeve 5. The coupling element 9 is guided in the illustrated embodiment in a protective sleeve 12 which rests in the neck region of the patient to avoid a direct rubbing of the coupling element 9 on the skin during a movement of the arm supplied.

FIGS. 4a-4d show various states of movement or movement sections when using the prosthetic shaft holding device. In FIG. 4 a, the arm prosthesis is swung forward, this leading to the front extension 7 being moved in the direction of the collarbone. Correspondingly, the dorsal extension 6 is moved away from the guide 10. This movement causes the coupling element 9 slides along within the guide 10 and ensures the free mobility of the prosthesis.

FIG. 4 b shows the prosthesis shaft holding device in a state in which the elbow or arm is curved backwards, the dorsal extension 6 is thereby displaced in the direction of the guide 10, the coupling element 9 slides inside the guide 10, so that the front extension 7 despite the connection with the dorsal extension 6 can move away from the collarbone. The position according to FIG. 4b is shown in the side view in FIG. 4c, the position according to FIG. 4a is shown in the side view in FIG. 4d. It can be clearly seen that the dorsal extension 6 is guided forward during a movement in the shoulder joint, while the frontal extension 7 is moved over the shoulder blade in the direction of the guide 10. The movement of the frontal and dorsal extensions 6, 7 is fixed by the coupling element 9 and the almost fixed position of the guide 10 in the region of the spinal column. The guide 10 is positioned at a location where no or only a slight displacement of the guide 10 relative to the torso 1 is to be expected, as it is positioned approximately in the transition from the cervical spine to the thoracic spine or upper third of the thoracic spine.

FIG. 5 shows a detailed illustration of the securing part 2 with the back section 3 and the guide 10 fastened there. In the exemplary embodiment shown, the guide 10 is designed as a quadrangular wire element with a substantially closed cross section. About a fabric bag 13, the guide 10 is hinged but fixed substantially stationary on the securing part 2. The textile element 13 may be glued or sewn or welded. In principle, it is also possible to make the position of the guide 10 on the securing part 2 variable in order to allow adaptation to the patient.

The coupling element 9 is placed around a free leg of the guide 10 around and can be moved along in a sliding guide, so that a length compensation and a free movement of the coupling element 9 is ensured. The upper illustration shows the shape of the guide 10 in a single representation.

As an alternative to a separate guide element 10 made of a wire or a plastic, the guide 10 can also be formed within the securing part 2 by two slots, through which the coupling element 9 is passed. The design with two slots has the advantage that the coupling element 9 predominantly at the top and on the surface surface of the security part 2 is guided in order to avoid a chafing movement on the skin or a tissue as far as possible.

The prosthesis holding device according to the invention, via the coupling element, mechanically fixes the prosthesis shaft 4 via the securing part 2 to the torso 1 of the prosthesis user. Due to the fact that in the frontal chest area only relatively narrow straps or belt-like portions are guided along and the coupling element 9 is deflected in the back in the guide 10, advantageously in the upper thoracic spine, the physiological gait of the user is not affected, since the movement is not restricted in the shoulder joints. We also allowed the swinging of the prosthetic arm and the contralateral, unsupported arm in mobility not restricted. The entire prosthesis holding device is removable from the prosthesis shaft 4, it can thus be washed and cleaned easily. The securing part 2 can be separated from the rest of the prosthesis-associated part of the prosthesis holding device by detaching the coupling element 9 from the cuff or the sleeve 5 with its dorsal or frontal extensions 6, 7. This modular design makes it possible to manufacture prefabricated sleeves 5 or collars adapted to different prosthesis stems 4 and to freely combine them with likewise prefabricated securing parts 2, depending on which design best fits the particular patient.

In principle, it is also possible that the coupling element 9 is fixed directly to the prosthesis shaft 4, so no outer mounting sleeve 5 or sleeve is present, which completely surrounds the prosthesis shaft 4 on the outside. Instead, the coupling element 9 can be fixed directly to the prosthesis socket 4 via form-locking elements or hook-and-loop fasteners, optionally in a protective sleeve 12 or on a protective pad, in order to prevent direct rubbing of the movable coupling element 9 on the skin. If possible, the securing part 2 is formed over such a large area that no or almost no direct contact of the coupling element 9 on the skin, in particular in the region of the collarbone on the supplied side. By the belt guide, so the slide of the coupling element 9, in the back region, the swinging of the prosthetic arm is favored when walking. The prosthesis shaft support device can be attracted and deposited independently for the patient and can be adapted to different prosthesis stems 4 by simple measures. The material of both the securing part 2 and the sleeve 5 with the frontal and dorsal extensions 6, 7 may be a textile material, for example using a 3D spacer knit, as well as foam materials, such as open-cell foams einsetzbar to a high wearing comfort to ensure a minimization of moisture accumulation.

Claims

claims

A prosthetic shaft holding device for securing a prosthetic socket (4) to an upper extremity, comprising a securing part (2) which can be guided along the torso (1) below the axilla of the contralateral, unsupplied side of a patient, and with a coupling element (9), which can be fixed to the prosthesis socket (4) and can be connected to the securing part (2), characterized in that the coupling element (9) is displaceably mounted on the securing part (2).

2. prosthesis shaft holding device according to claim 1, characterized in that the coupling element (9) releasably on the prosthesis shaft (4) is fastened bar.

3. Prosthetic shaft holding device according to claim 1 or 2, characterized in that the coupling element (9) is positively secured to the prosthesis shaft (4) or arranged on a sleeve or sleeve (5) which is releasably attachable to the prosthesis shaft (4).

4. Prosthetic sheep holding device according to one of the preceding claims, characterized in that the coupling element (9) is designed in several parts.

5. Prosthetic shaft holding device according to one of the preceding claims, characterized in that the coupling element (9) has a flexible tension element, which is movably guided in a fixed to the securing part (2) or guide (10).

6. Prosthetic shaft holding device according to one of the preceding claims, characterized in that the coupling element (9) is guided displaceably in a protective sleeve (12) or on a protective pad, wherein the protective sleeve (12) or protective pad in the applied state in the torso (1) ,

7. Prosthetic sheep holding device according to one of the preceding claims, characterized in that the coupling element (9) is guided along in the applied state at the front and the back of the supplied shoulder.

8. prosthesis shaft holding device according to one of the preceding claims, characterized in that the securing part (2) is formed as a flat blank and an opening (14) as an arm feedthrough or is formed as a loop with end-side connecting elements.

9. Prosthetic sheep holding device according to one of the preceding claims, characterized in that the securing part (2) has a padding (15) in the axillary region.

10. prosthesis shaft holding device according to one of the preceding claims, characterized in that the securing part (2) in the applied state dorsally beyond the median plane in the direction of the prosthesis shaft (4) protrudes.

11. Prosthetic sheep holding device according to one of the preceding claims, characterized in that the securing part (2) and / or the coupling element (9) is made of a textile material, spacer fabric and / or foam material.

12. Prosthetic sheep holding device according to one of the preceding claims, characterized in that the coupling element (9) is formed as a loop.

13. System of a prosthetic shaft holding device according to one of the preceding claims and a prosthesis stem.